专员I，TMF运营
Associate I, TMF Operations
我们是谁
我们是一家全球性的中型CRO，不断突破界限，创新和发明，因为治愈世界上最顽固疾病的道路不是由那些谨慎行事的人铺就的。它是由那些采取开创性、创造性方法并以高质量和卓越执行力实施的人所构建的。
我们是Worldwide Clinical Trials，我们是一支超过3500名专家、聪明的思考者、梦想家和实干家组成的全球团队，我们正在以最好的方式改变世界对CRO的体验。
我们的使命是每天带着激情和目标工作，改善生活，我们正在寻找同样重视这一追求的人。
为什么选择Worldwide
我们认为每个人都在为患者及其护理者带来巨大影响方面发挥着重要作用。从我们亲力亲为、平易近人的领导，到我们紧密协作、互相支持的团队，我们致力于让来自不同背景和经验的专业人士取得成功。我们优先培养一个多元且包容的环境，持续促进协作和创造力。我们自豪地成为这样一个职场，在这里，人们可以做真实的自己，并每天被激励做出最好的工作。加入我们吧！
在Worldwide，记录管理合规部门所做的工作
TMF运营负责按照相关标准操作规程、国家特定法规和行业最佳实践，严格处理、维护和归档所有关键文件。在整个Worldwide Clinical Trials，我们的协作和创新文化推动我们在临床研究中追求卓越，并对每位患者的生活产生有意义的影响。我们TMF运营部门的职位具有全球范围，有机会经常与Worldwide项目团队成员合作。
你将负责
· 根据相关标准操作规程（SOP）和工作流程，履行“TMF审批人”的职责。
· 处理、审查和解决多个研究的试验主文件（TMF）文档，包括电子版和纸质版。
· 使用各种电子文档管理系统和电子TMF系统来审查、分类和处理关键文件。
· 直接与RMC主管沟通，报告与TMF相关的趋势和问题。
· 及时向RMC主管上报任何TMF质量问题。
· 为RMC主管提供行政支持，包括但不限于归档和管理。
查看英文原文
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Records Management Compliance Department does at Worldwide
TMF Operations handles the processing, maintenance and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country-specific regulations, and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation is what propels us in our pursuit of excellence in clinical research and making a meaningful impact on every patient's life. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team
What you will do
- Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
- Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
- Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
- Escalate any TMF Quality issues in a timely manner to RMC Lead.
- Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
- Perform additional tasks as assigned by their Line Manager.
What you will bring to the role
- Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
- Possess excellent written and verbal communication skills to clearly and concisely present information.
- Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
- Exercise sound judgment and ability to identify decisions requiring supervisory approval.
- Demonstrate proficiency in Microsoft Word and Excel.
- Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills. General understanding of clinical research principles and processes.
What you will bring to the role
- University Degree preferred
- Minimum 6 months of relevant TMF experience
- Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Originally posted on Himalayas